The FDA is a trusting organization

The FDA classifies medicaI devices into three groups. Devices, like pacemakers, that are implanted or sustain or support life and could put patients at serious risk are put in Class I. Devices that are similar to what is on the market are put into Class II. Everything else — bandages, dental floss, forceps and the like — are put into Class I, which means that the devices don't require approval by the FDA because they present a low risk. 

OtisMed decided that its OtisKnee guide fell into Class I. So, the company registered the device with the FDA as Class I and began selling it. From 2006 to 2009 they sold 18,000 devices.

In 2009 the FDA informed the company that it had not demonstrated that the guides were safe. The notice said that the OtisKnee was a Class III device and that OtisMed's submission was missing data about how patients had fared, raising concerns about failure rates. The company then applied for FDA approval as a Class III device. They did not receive approval as the FDA determined that the company failed to show that the product was safe and effective. Yet, the CEO of OtisMed continued to have the device distributed.

The Justice Department went after the company and the CEO. The company settled for $80,000,000. The now former CEO pleaded guilty and is awaiting final sentencing.

The question in my mind is why the FDA allows companies that sell devices that are placed inside our bodies to determine what class the device falls in.